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David Dore

David Dore is a pharmacoepidemiologist. After the FDA permits public use of a drug, Dore and others like him assess the drug’s safety and effectiveness across the broad population of actual users.

With a doctoral degree in pharmacy from the University of Rhode Island, David Dore certainly could have earned a decent living and provided an important service. But Dore’s curiosity and intellectual drive turned out to be too great to be contained in a small plastic jar with a push-and-turn cap.

“In the pharmacy you can absolutely help patients on a one-by-one basis,” said Dore, who after a brief retail pharmacy career, went on to earn a Ph.D. in epidemiology at Brown in 2008. “But when you view health from a public health standpoint, good information can help anywhere from dozens to millions of patients.”

Dore is a pharmacoepidemiologist. When the FDA lets a drug loose in the market, folks like him have the task of figuring out whether a drug is proving to be safe and effective in the real world. While the FDA’s judgment is typically based on controlled, randomized clinical trials submitted by the drug companies, Dore’s analyses are based on outcomes in everyday medical practice. It’s a bit like the difference between the mileage measured by the Environmental Protection Agency and the mileage drivers observe on the roads.

At first Dore worked in industry, performing commissioned analyses of drug safety and effectiveness for i3 Drug Safety, a consultancy in Waltham, Mass., affiliated with the insurer UnitedHealth Care. Now, as an assistant professor in Brown’s new Department of Health Services Policy and Practice, he’ll set his own agenda for investigating the impact that drugs have on populations of patients.

In his work at i3 he had some of the impact he hoped, helping to clear up unnecessary concerns about some drugs and showing that others might not be quite what patients and their doctors bargained for.

For example, Dore and a team of colleagues analyzed UnitedHealth Care claims records of more than 250,000 people and more than 2,500 medical records to determine whether there was an association between the anti-diabetes drug exenatide and acute pancreatitis, as some doctors had begun to suspect. In the June issue of the journal Diabetes, Obesity and Metabolism, Dore was the lead author on a paper that suggested exenatide was probably not affecting the occurrence of pancreatitis.

Sometimes the news was more disappointing. In May 2010, Dore was the lead author of research published in Contraception that confirmed concerns about the transdermal contraceptive patch, Ortho Evra. The patch releases far more estrogen than contraceptive pills and without necessarily being any more effective, it doubled the risk of venous thromboembolism, an often-fatal circulatory disease.

As satisfying as those results were, Dore’s work at i3 was dictated by client needs, some of which were inspired more by bureaucratic requirement than public health interest. Dore yearned for the chance to ask his own questions. He had been an adjunct assistant professor at Brown since graduating, but when he saw the full-time faculty job that would ultimately become his open up at Brown, he jumped.

“What I think is unique about Brown is that focus on pharmacoepidemiology is within the health services policy and practice department, which means it has a flavor of policy and that’s intriguing to me,” he said. “It’s an exciting time to be here. The department is growing and there is a plan to become a school of public health soon, yet it still has a small feel.”

In a smaller program, Dore explained, he’ll frequently work with colleagues with a wide variety of perspectives in epidemiology, policy, biostatistics, and other related fields. In a bigger program, he’d risk more often ending up in a set of narrow interactions with other pharmacoepidemiologists.

One of the areas Dore says he’s interested in pursuing at Brown is refining methods for “comparative effectiveness” research into how different drug therapies perform in subpopulations of patients. Dore wants to develop methods to figure out, given an overall study of a drug’s risks and benefits, which subgroups (e.g. men over 50, or Hispanic women) should certainly get the treatment and which perhaps should not.

“The expectation is that underlying an average effect is variability in the benefit,” he said. “But when you have defined these subgroups how do you address differential bias across the subgroups?”

A simple example of bias comes up in studies of things like cholesterol-fighting statins. Compare people who take them to people who don’t and you might see a disappointingly high number of heart attacks in people who do. But many of those people are on the drug because of their elevated risk of heart disease, so a high rate of heart attacks perhaps should be expected. Accounting for bias related to characteristics of patients who are prescribed drugs allows researchers to determine whether the drug is truly effective, for instance because it is observed to actually reduce heart attacks when bias is adequately addressed.

With government studies showing that one of every two U.S. residents has taken a prescription drug in a given month, including nine out of 10 seniors, the importance of this kind of research is clear.

Out from behind the pharmacy counter and the constraints of consultancy, Dore is ready to dive in.